Quality Engineer

Job Description

Job Description

Join a team that improves patient outcomes through innovative and flexible solutions to the acute care market! When you work for Skytron, you get so much more than a job, including:

• Comprehensive benefits package, beginning on day one
• Annual Bonus
• Paid vacation, personal days, and holidays
• 401(k) and Profit sharing
• Tuition reimbursement program
• Onsite gym
• Family-owned and operated business

As the Quality Engineer, you will:

• Develop, implement, and maintain quality processes in compliance with FDA, ISO, and other applicable regulatory requirements
• Lead and support Corrective and Preventive Action (CAPA) activities, including: root cause analysis, effectiveness verification and documentation
• Investigate nonconformances (NCs) and assist with trending and reduction initiatives
• Perform incoming, in-process, and final inspections of medical devices to verify compliance with product specifications and quality standards
• Collaborate with R&D and Production teams to support design transfer activities, process validations (IQ/OQ/PQ), and product or process changes
• Participate in supplier quality management activities, including: supplier audits, supplier performance, and continuous improvement initiatives
• Conduct and support internal quality audits to evaluate the effectiveness of the Quality Management System (QMS) and ensure regulatory compliance
• Assist in the preparation for, and actively participate in, regulatory inspections and third-party audits; demonstrating compliance and audit-readiness

For success in this role, you will:

• Capably handle required administrative functions and meet productivity standards
• Verify work to ensure accurate results, requiring minimal rework
• Follow work instructions, procedures, safety guidelines, and company policies
• Work cross-functionally with Operations, Sales, Product Management and Service for goal alignment and results
• Give customer needs priority, responding quickly to concerns and demonstrating a desire to assist others
• Be detail-oriented and possess the ability to multi-task, work under pressure, and meet deadlines
• Listen to others, expressing ideas with tact and clarity
• Be internally motivated and work well with minimal supervision
• Devise workable solutions or consult with secondary resources to devise solutions
• Hold a Bachelor's degree in Engineering, Life Sciences, or related technical discipline
• Bring a minimum of 3 years of experience and demonstrated success in a quality role within the medical device field or another highly regulated industry (strongly preferred)
• Demonstrate a strong working knowledge and understanding of FDA 21 CFR 820, ISO 13485, and Risk Management (ISO 14971)
• Have hands-on experience with CAPA processes, root cause analysis, internal audits, and process validation activities
• Possess prior experience using electronic Quality Management System (eQMS) platforms
• Be highly proficient in Microsoft Office applications, including: Word, Excel, and PowerPoint
• Possess a Certified Quality Engineer (CQE) or similar certification (Preferred)

If you need assistance with any aspect of the application process or would like to request a paper application, please contact Skytron' s Human Resources Department at 800.759.8766.

We are an equal opportunity employer. We welcome applicants of all backgrounds and hire based on skills, experience, and qualifications. All qualified applicants will be considered without regard to race, color, religion, sex (including gender identity and sexual orientation), national origin, age, disability, veteran status, or other protected characteristics protected by law.